Class II — MicroAire Surgical Instruments, LLC
| Recalling firm | MICROAIRE SURGICAL INSTRUMENTS, LLC |
|---|---|
| Registered facility | MICROAIRE SURGICAL INSTRUMENTS LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) |
| Product | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone |
| Quantity | 42 |
| Distribution | US Distribution. |
| Initiated | 2017-05-22 |
| Classified | 2018-01-26 |
| Terminated | 2018-08-29 |
| Recall number | Z-0412-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MicroAire Surgical Instruments, LLC (Z-0412-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78687/
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